STIRA PHARMACEUTICALS LLC
Form 483 issued November 5, 2021 · Fairfield, New Jersey
- Investigator
- Lata Mathew
- Observations
- 1
- Pages
- 2
- FEI number
- 3017224277
In short: On November 5, 2021, FDA issued a Form 483 with 1 observation to STIRA PHARMACEUTICALS LLC in Fairfield, New Jersey (FEI 3017224277). The investigator was Lata Mathew. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Lata Mathew
24 documents · 2017–2024
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmSTIRA PHARMACEUTICALS LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at STIRA PHARMACEUTICALS LLC?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected STIRA PHARMACEUTICALS LLC?
Lata Mathew is named on this Form 483. Each investigator has a profile showing what they cite most.
When was STIRA PHARMACEUTICALS LLC inspected by FDA?
This Form 483 is dated November 5, 2021.
How do I get the full Form 483 for STIRA PHARMACEUTICALS LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.